{
"info": {
"nct_id": "NCT03546972",
"official_title": "Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise",
"inclusion_criteria": "* Body Mass Index (BMI) >= 27 kg/m^2.\n* At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk > 20% or a 5 year risk >1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion.\n* 12 months without a period/menstrual cycle or having had a bilateral oophorectomy.\n* Ability to take digital time stamped photos.\n* Internet access (daily).\n* Reports being proficient in English (can read/write and speak fluently).\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 30 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible.\n* Has a current measured BMI less than 27 kg/m^2.\n* Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.\n* Currently being actively treated for cancer other than nonmelanoma skin cancer.\n* Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.\n* Reported current diagnosis or history of type I diabetes or type 2 diabetes.\n* Reported use of oral antidiabetic agents (OADs).\n* Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).\n* Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator).\n* Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide, liraglutide).\n* Fasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.\n* Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Body Mass Index (BMI) >= 27 kg/m^2.",
"criterions": [
{
"exact_snippets": "Body Mass Index (BMI) >= 27 kg/m^2",
"criterion": "Body Mass Index (BMI)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 27,
"unit": "kg/m^2"
}
}
}
]
},
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{
"exact_snippets": "Body Mass Index (BMI) >= 27 kg/m^2",
"criterion": "Body Mass Index (BMI)",
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"requirement_type": "value",
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"operator": ">=",
"value": 27,
"unit": "kg/m^2"
}
}
}
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}
},
{
"identified_line": {
"line": "* At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk > 20% or a 5 year risk >1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion.",
"criterions": [
{
"exact_snippets": "Gail model lifetime risk > 20%",
"criterion": "Gail model lifetime risk",
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"expected_value": {
"operator": ">",
"value": 20,
"unit": "%"
}
}
},
{
"exact_snippets": "5 year risk >1.66%",
"criterion": "5 year risk",
"requirement": {
"requirement_type": "risk",
"expected_value": {
"operator": ">",
"value": 1.66,
"unit": "%"
}
}
},
{
"exact_snippets": "history of deleterious BRCA1/2 mutation",
"criterion": "deleterious BRCA1/2 mutation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... mantle radiation",
"criterion": "mantle radiation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ductal cancer in situ",
"criterion": "ductal cancer in situ",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of high risk premalignant breast lesion",
"criterion": "high risk premalignant breast lesion",
"requirement": {
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"expected_value": true
}
}
]
},
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"or_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Gail model lifetime risk > 20%",
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"operator": ">",
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"unit": "%"
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},
{
"exact_snippets": "5 year risk >1.66%",
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"requirement_type": "risk",
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"operator": ">",
"value": 1.66,
"unit": "%"
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}
}
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},
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"exact_snippets": "history of deleterious BRCA1/2 mutation",
"criterion": "deleterious BRCA1/2 mutation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... mantle radiation",
"criterion": "mantle radiation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ductal cancer in situ",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of high risk premalignant breast lesion",
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"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* 12 months without a period/menstrual cycle or having had a bilateral oophorectomy.",
"criterions": [
{
"exact_snippets": "12 months without a period/menstrual cycle",
"criterion": "menstrual cycle",
"requirement": {
"requirement_type": "absence_duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
},
{
"exact_snippets": "having had a bilateral oophorectomy",
"criterion": "bilateral oophorectomy",
"requirement": {
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"expected_value": true
}
}
]
},
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"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "12 months without a period/menstrual cycle",
"criterion": "menstrual cycle",
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"requirement_type": "absence_duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
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},
{
"and_criteria": [
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"exact_snippets": "having had a bilateral oophorectomy",
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"requirement": {
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"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Ability to take digital time stamped photos.",
"criterions": [
{
"exact_snippets": "Ability to take digital time stamped photos.",
"criterion": "ability to take digital time stamped photos",
"requirement": {
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"expected_value": true
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Ability to take digital time stamped photos.",
"criterion": "ability to take digital time stamped photos",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Internet access (daily).",
"criterions": [
{
"exact_snippets": "Internet access (daily)",
"criterion": "internet access",
"requirement": {
"requirement_type": "frequency",
"expected_value": "daily"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Internet access (daily)",
"criterion": "internet access",
"requirement": {
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"expected_value": "daily"
}
}
]
}
},
{
"identified_line": {
"line": "* Reports being proficient in English (can read/write and speak fluently).",
"criterions": [
{
"exact_snippets": "proficient in English (can read/write and speak fluently)",
"criterion": "English proficiency",
"requirement": {
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"expected_value": "proficient"
}
},
{
"exact_snippets": "proficient in English (can read/write and speak fluently)",
"criterion": "English proficiency",
"requirement": {
"requirement_type": "skills",
"expected_value": [
"read",
"write",
"speak"
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}
}
]
},
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"and_criteria": [
{
"exact_snippets": "proficient in English (can read/write and speak fluently)",
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}
},
{
"exact_snippets": "proficient in English (can read/write and speak fluently)",
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"write",
"speak"
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}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
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{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 30 Years",
"criterions": [
{
"exact_snippets": "minimum age of 30 Years",
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"expected_value": {
"operator": ">=",
"value": 30,
"unit": "Years"
}
}
}
]
},
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"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 70 Years",
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{
"exact_snippets": "maximum age of 70 Years",
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"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
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"exact_snippets": "maximum age of 70 Years",
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"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible.",
"criterions": [
{
"exact_snippets": "Previous participation in this trial",
"criterion": "previous participation in this trial",
"requirement": {
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"expected_value": false
}
},
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}
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}
}
]
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"logical_structure": {
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"and_criteria": [
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"exact_snippets": "Previous participation in this trial",
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"expected_value": false
}
},
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}
},
"else_criteria": null
}
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{
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"value": 27,
"unit": "kg/m^2"
}
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}
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"operator": "<",
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"unit": "kg/m^2"
}
}
}
}
},
{
"identified_line": {
"line": "* Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.",
"criterions": [
{
"exact_snippets": "unwilling to use Continuous Glucose Monitor (CGM)",
"criterion": "willingness to use Continuous Glucose Monitor (CGM)",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "requires daily blood sampling by finger pricks",
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}
}
]
},
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"exact_snippets": "unwilling to use Continuous Glucose Monitor (CGM)",
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}
}
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"exact_snippets": "requires daily blood sampling by finger pricks",
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]
}
},
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"identified_line": {
"line": "* Currently being actively treated for cancer other than nonmelanoma skin cancer.",
"criterions": [
{
"exact_snippets": "Currently being actively treated for cancer",
"criterion": "active cancer treatment",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "cancer other than nonmelanoma skin cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "nonmelanoma skin cancer"
}
}
]
},
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"exact_snippets": "Currently being actively treated for cancer",
"criterion": "active cancer treatment",
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"expected_value": true
}
},
{
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"exact_snippets": "cancer other than nonmelanoma skin cancer",
"criterion": "cancer type",
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"expected_value": "nonmelanoma skin cancer"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.",
"criterions": [
{
"exact_snippets": "Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.",
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}
}
]
},
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}
}
}
},
{
"identified_line": {
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{
"exact_snippets": "Reported current diagnosis or history of type I diabetes",
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"expected_value": true
}
},
{
"exact_snippets": "Reported current diagnosis or history of ... type 2 diabetes",
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}
}
]
},
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}
},
{
"exact_snippets": "Reported current diagnosis or history of ... type 2 diabetes",
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}
}
]
}
},
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"identified_line": {
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{
"exact_snippets": "Reported use of oral antidiabetic agents (OADs)",
"criterion": "oral antidiabetic agents (OADs)",
"requirement": {
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}
}
]
},
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"exact_snippets": "Reported use of oral antidiabetic agents (OADs)",
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}
}
}
},
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"identified_line": {
"line": "* Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).",
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"exact_snippets": "Current use of any drug (except metformin)",
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}
},
{
"exact_snippets": "interfere with the glucose metabolism",
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}
]
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},
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"identified_line": {
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{
"exact_snippets": "Previous or current treatment with any insulin regimen other than basal insulin",
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"exact_snippets": "short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator",
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}
},
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"exact_snippets": "short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator",
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}
}
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}
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"identified_line": {
"line": "* Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide, liraglutide).",
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{
"exact_snippets": "Previous or current treatment with GLP-1 receptor agonists",
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}
},
{
"exact_snippets": "exenatide, liraglutide",
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]
}
}
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"exact_snippets": "Previous or current treatment with GLP-1 receptor agonists",
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}
},
{
"exact_snippets": "exenatide, liraglutide",
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}
}
]
}
},
{
"identified_line": {
"line": "* Fasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.",
"criterions": [
{
"exact_snippets": "Fasting blood glucose level > 126",
"criterion": "fasting blood glucose level",
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"operator": ">",
"value": 126,
"unit": "mg/dL"
}
}
},
{
"exact_snippets": "glycosylated hemoglobin (HbA1c) > 7%",
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"operator": ">",
"value": 7,
"unit": "%"
}
}
}
]
},
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{
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"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 126,
"unit": "mg/dL"
}
}
},
{
"exact_snippets": "glycosylated hemoglobin (HbA1c) > 7%",
"criterion": "glycosylated hemoglobin (HbA1c)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 7,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.",
"criterions": [
{
"exact_snippets": "Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.",
"criterion": "suitability for the study",
"requirement": {
"requirement_type": "investigator's assessment",
"expected_value": "unsuitable"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.",
"criterion": "suitability for the study",
"requirement": {
"requirement_type": "investigator's assessment",
"expected_value": "unsuitable"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}